Mazor Robotics, which develops technology to help surgeons more accurately and securely undertake spine surgery, has received approval from the FDA in the United States to market its Renaissance system with 3D imaging technology. The new system will make it far easier for doctors to plan and carry out spinal surgery – using the robot-based operating system while in the midst of surgery to accurately carry out the operation without using the pre-op 2D imaging that is usually used.
With the FDA approval, says the company, Renaissance is now a complete solution for spine surgeons to accurately plan and carry out operations – before ever picking up a knife. The system is based on (and supercedes) Mazor's original SpineAssist technology, which uses robot technology to plan precise locations for spinal fusion screw placement and related surgical interventions. Now, with the addition of 3D imaging, doctors will be able to dramatically shorten the time needed for completion of an operation, and enable doctors to perform operations under difficult circumstances, such as during emergency situations when it is impossible to get a good look at the area to be operated upon using the current 2D CT (X-ray computed tomography) imaging systems.
The ability to do on the fly 3D imaging, says the company, which does its development at its headquarters in Herzliya, will enable doctors to conduct surgery without subjecting the patient to a CT examination, the minimizing patients' exposure to radiation. The system has already been very successful in minimizing the need for repeat surgery to correct problems that result from a previous round of surgery – a very common scenario for spine patients.
The main reason for repeat operations, says the company, is because of incorrect placement of implants and screws, which usually can only be detected post-surgery, using current tools. The repeated surgeries cost the hospital money, and further weaken the patient. With the 3D-activated Renaissance robotic system, doctors can much more accurately determine where and how to place screws and implants, drastically reducing the need for repeated surgeries.
Mazor Robotics’ surgical guidance technology has been successfully used in a wide variety of spinal procedures--from routine cases to the most complex cases. In fact, says company CEO Ori Hadomi, many of these cases would not even be attempted without Mazor Robotics’ surgical guidance technology. “We are proud of having received an additional approval by the FDA, and now doctors will be able to use the Renaissance robotic system to its full potential,” says Hadomi.